Authorisation of Biopharmaceuticals, Biosimilars, and Advanced Therapies in Europe

The percentage of biopharmaceuticals among newly authorised medical products is estimated to be in the range of 30 percent to 50 percent. This three-day training course is focused on the contribution of biopharmaceuticals to new drug candidates and their increasing relevance to the drug development community. Learn about these and other issues:
Classical biological and biotechnology-derived medical products
How to compile information on manufacturing
How changes in the manufacturing process can impact quality
How to characterise and control manufacturing processes and safety procedures required for infectious agents
The particulars of the non-clinical/clinical development of biopharmaceuticals
How to develop biosimilar medicinal products

Gain insight into data requirements for creating the Common Technical Document (CTD) and the Investigational Medicinal Product Dossier (IMPD). The course will review a case study on a monoclonal antibody and how to develop a protein without a relevant animal model. Issues of advanced therapies and biosimilar product classes will be outlined.